FDA eases enforcement for some e-cigarettes and nicotine pouches under review

The Food and Drug Administration is drawing a narrower enforcement line around unauthorized e-cigarettes and nicotine pouches, giving companies with applications under review more room to keep selling while Washington sorts out the paperwork. The agency said on May 8 that it would not prioritize action against certain products covered by its new guidance, a shift that could protect some manufacturers from sudden crackdowns even as the products remain unauthorized under federal law.

The policy is laid out in a final guidance titled “Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization,” scheduled for publication in the Federal Register on May 12, 2026. It covers certain electronic nicotine delivery systems and oral nicotine pouch products that are being marketed without premarket authorization, but only if the companies behind them have submitted marketing applications that have been accepted for review or supplemental filings that have been pending for more than 180 days. In practice, that creates a legal gray zone: some products may stay on the market while the FDA continues reviewing whether they are appropriate for the protection of public health.

The agency said the products still remain adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act, and it stressed that it would continue to act against items that raise sharper youth concerns. That includes products with cartoon-like imagery or packaging designed to resemble a toy, phone or gaming platform. The FDA has also warned about illegal e-cigarettes styled to look like smart devices, with features such as gaming functions, smartphone connectivity, notifications or music, and about packaging meant to mimic milk cartons, soft drink bottles and slushies.

The enforcement change arrives with the scale of the illicit market still stark. The FDA says it has authorized 41 e-cigarettes, a tiny slice of the products circulating in the United States. In 2025, the Justice Department and the FDA said a nationwide sweep seized more than 2.1 million illicit vaping products from five distributors and six retailers across seven states. The Government Accountability Office later said the Justice Department had taken 88 civil or criminal enforcement actions since fiscal 2022, while thousands of unauthorized products were still being sold as of 2024.

The move appears designed to conserve enforcement resources while still preserving some guardrails, but it also raises a familiar question for public health advocates: whether the FDA is targeting the most harmful actors or quietly easing pressure on an industry that has learned how to live in regulatory limbo. Tobacco companies, including Philip Morris International, Altria, Reynolds American and Turning Point Brands, have pushed for a faster and clearer review process, and the FDA has already shown it can move quickly in some cases, authorizing 20 ZYN nicotine pouch products in January 2025 after an extensive scientific review. Even so, the agency has recently slowed some pouch reviews again over concerns about youth uptake and risks to non-users, signaling that the review system is speeding up and tightening at the same time.